Effect of a Preparation Video on Preoperative Anxiety in Children Undergoing Dental Treatment Under GA

NCT06612398 | Completed

• 1 other identifier: 72/149/2022
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The present study investigated the effect of an animated preoperative preparation video in mitigating preoperative anxiety among children receiving comprehensive dental treatment under General Anesthesia (GA).

Conditions

Preoperative Anxiety

Outcome Measures

Primary Outcomes (2)

• modified Yale Preoperative Anxiety Scale

  Observational anxiety scale, values (23.3-100) with higher scores indicating higher levels of anxiety

  1 day

• Visual Facial Anxiety Scale

  Self-report anxiety scale, values (0-10) with higher scores indicating higher levels of anxiety

  1 day

Secondary Outcomes (2)

• Face, Legs, Activity, Cry, Consolability scale

  1 day

• Pediatric Anesthesia Emergence Delirium scale

  1 day

Study Arms (2)

Standard of care

NO INTERVENTION

Participants received the standard care provided upon arrival and being admitted to the hospital, involving only a verbal explanation of the anaesthesia induction process.

Preoperative preparation video

EXPERIMENTAL

On the night before the surgery, participants were presented with an animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home.

Behavioral: Preoperative preparation video

Interventions

Preoperative preparation video BEHAVIORAL

An animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home.

Preoperative preparation video

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who are healthy, with American Society of Anesthesiologists (ASA) Grade 1 and 2 status.
• Age 4-7 years.
• Children undergoing GA for the first time who require comprehensive dental rehabilitation.

You may not qualify if:

• Presence of a systemic disease, as well as mental, cognitive, and intellectual disabilities.
• Presence of visual or auditory disability.
• Participants who refuse to answer subjective scales due to heightened anxiety levels.
• Participants with no access to internet services.
• Presence of active severe dental pain and/or facial abscess as it could affect the participant's state anxiety.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan

Location

Related Publications (29)

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Study Officials

• Mawia Bataineh, Doctor

  Jordan University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research Assistant who evaluated patient's anxiety levels did not know who watched the intervention and who did not.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 25, 2024
• Study Start: February 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 25, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)